Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Comtan® (entacapone) in the United States
ORION CORPORATION STOCK EXCHANGE RELEASE 15 December 2010 AT 4.25 PM EET
Company states generic competition is not imminent
Orion Corporation has been informed that an Abbreviated New Drug Application (ANDA) has been filed by Mylan Pharmaceuticals Inc. (Mylan) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. At this point, the ANDA review process is just beginning and generic competition is not imminent.
Mylan has filed so-called Paragraph IV certifications challenging Orion U.S. patent No. 5,446,194 and U.S. Patent No. 6,599,530 covering Comtan and listed in the Orange Book, the FDA's official listing of approved drug products.
Paragraph IV certifications are not uncommon in the U.S. Orion is, together with Novartis, currently evaluating its legal options to protect its rights. Under the U.S. system, if a patent owner brings a lawsuit against an ANDA applicant within a certain time limit, there will be a 30-month stay of final FDA approval. During that time, the FDA can give only a tentative approval to the ANDA applicant unless the applicant obtains a favorable decision on all challenged patents in the lawsuit.
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426 3054, gsm +358 50 966 3054
Orionintie 1A, FI-02200 Espoo
Orion is an innovative European R&D-based pharmaceutical and diagnostic company with a special emphasis on developing medicinal treatments and diagnostic tests for global markets. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. Orion's pharmaceutical R&D focuses on the following core therapy areas: central nervous system drugs, cancer and critical care drugs, and Easyhaler® pulmonary drugs.
The Group's net sales in 2009 amounted to EUR 772 million. The Company invested EUR 95 million in research and development. At the end of 2009, the Group had a total of 3,100 employees, of whom 2,500 worked in Finland and 600 in other European countries. Orion's A and B shares are listed on NASDAQ OMX Helsinki.